Prescribing unproven cancer drugs: physician perspectives on expanded access and right to try. Issue 2 (25th October 2022)

• Record Type: Journal Article
• Authors: Manley, Haley; Sisk, Bryan A; Master, Zubin; Scott, Christopher Thomas
• Is Part Of: Journal of law and the biosciences. Volume 9:Issue 2(2022)
• Publication Date: 2022-10-25
• Subjects: Expanded Access -- Right to Try -- FDA -- ethics -- neuro-oncology -- Compassionate Use; Life sciences -- Law and legislation -- Periodicals; Science and law -- Periodicals; Law and biology -- Periodicals; Biotechnology -- Law and legislation -- Periodicals; Bioethics -- Periodicals; 344.0957
• DOI: 10.1093/jlb/lsac031
• Languages: English
• ISSNs: 2053-9711

Abstract

Abstract: Background: For gravely ill patients who have no treatment options and who are ineligible for clinical trials, the US Food and Drug Administration (FDA) established the Expanded Access Program (EAP). Motivated by efforts to weaken FDA regulation and sold as providing greater access to experimental drugs, the federal Right to Try Act (RTT) was passed in 2017. It reduces FDA oversight by not requiring physicians to report safety data and foregoes approval of protocols by local institutional review boards. Methods: This study explored the views of 17 neuro-oncologists from 15 different academic medical centers with varying experience with EAP and RTT using convenience sampling. We conducted semi-structured interviews and qualitative analysis to identify emerging themes. Results: Most oncologists were confused between the two pathways, had little familiarity with RTT, and had little knowledge about experimental medicine available through either pathway. Oncologists reported a preference of enrolling patients in clinical trials over off-trial preapproval pathways with scant data. As a result, oncologists revealed concerns over properly evaluating risks for their patients. Conclusion: Our findings suggest that neuro-oncologists need better resources and clearer mechanisms at their institutions to help navigate EAP and RTT in order to counsel patients interested in experimental medicine.